§170.315(f)(7) Transmission to public health agencies — health care surveys
§ 170.315 (f)(7) Transmission to public health agencies – health care surveys—
Create health care survey information for electronic transmission in accordance with the standard specified in § 170.205(s)(1).
Applies to entire criterion
Standards Version Advancement Process (SVAP) Version(s) Approved
HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm
Optional
For more information, please visit the Standards Version Advancement Process (SVAP) Version(s) page.
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- Accessibility-centered design (§ 170.315(g)(5)): When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
This certification criterion was adopted at § 170.315(f)(7). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
- § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- End-user device encryption (§ 170.315(d)(7))
- Encrypt authentication credentials (§ 170.315(d)(12))
- Multi-factor authentication (MFA) (§ 170.315(d)(13))
- If choosing Approach 2:
- For each applicable privacy and security certification criterion not certified using Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the ONC Cures Act Final Rule at 85 FR 25710 for additional clarification.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial publication |
03-11-2024
|
- Regulation Text
-
Regulation Text
§ 170.315 (f)(7) Transmission to public health agencies – health care surveys—
Create health care survey information for electronic transmission in accordance with the standard specified in § 170.205(s)(1).
- Standard(s) Referenced
-
Applies to entire criterion
Standards Version Advancement Process (SVAP) Version(s) Approved
HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm
Optional
For more information, please visit the Standards Version Advancement Process (SVAP) Version(s) page.
- Certification Dependencies
-
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- Accessibility-centered design (§ 170.315(g)(5)): When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
- Privacy & Security Requirements
-
This certification criterion was adopted at § 170.315(f)(7). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
- § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- End-user device encryption (§ 170.315(d)(7))
- Encrypt authentication credentials (§ 170.315(d)(12))
- Multi-factor authentication (MFA) (§ 170.315(d)(13))
- If choosing Approach 2:
- For each applicable privacy and security certification criterion not certified using Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the ONC Cures Act Final Rule at 85 FR 25710 for additional clarification.
- Testing
-
Testing Tool
NIST General Validation Tool (GVT) - select NHCS CDA Release 3 validator in "Tool Scopes" section
Test Tool Documentation
National Health Care Surveys IG Release 1.2 Validator User Guide
National Health Care Surveys IG Release 1 Validator User Guide
Criterion Subparagraph Test Data (f)(7) SVAP Refer to NIST General Validation Tool (GVT) - select NHCS CDA Release 3 validator in "Tool Scopes" section
- Revision History
-
Version # Description of Change Version Date 1.0 Initial publication
03-11-2024
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the Certification Regulations page for a detailed description of the certification criterion with which these testing steps are associated. ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.
Note: The test step order does not necessarily prescribe the order in which the tests should take place.
Testing components
Paragraph (f)(7) Transmission to public health agencies – health care surveys
- The health IT developer identifies which of the survey type settings (Outpatient, Emergency Department) are applicable to the system under test. The user enters ONC-supplied patient-level test data that will be used to generate the health care survey information for each of the test cases identified as applicable (e.g., Outpatient (OP), Emergency Department (ED)) from the ONC: National Health Care Surveys Release (NHCS) IG Release 1.0 Validator or NHCS IG Release 1.2 Validator. All test cases are required that apply to the care setting(s) supported by the system under test.
- The Health IT Module creates a health care survey document in accordance with the standard at § 170.205(s)(1) HL7® Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1.0 or HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 DSTU Release 1.2 - US Realm for each test case.
OR
(Approved SVAP Version)
- The Health IT Module creates a health care survey document in accordance with the standard HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm.
- The tester verifies the Health IT Module creates the source health care survey content correctly through visual inspection of the system under test using the test data associated with the selected test case.
- The tester verifies the health care survey document is correct and without omission:
- The tester imports the health care survey CDA® document into the test tool for validation and uses the Validation Report produced by the test tool to verify that the Health IT module passes without error to confirm that the health care survey information document conforms to § 170.205(s)(1) and Errata for NHCS V1.0 or SVAP approved version.
- The health care survey information document conforms to the HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm.
- The tester uses the validation report to verify that the health care survey information document (CDA® document) generated by the Health IT Module is correct, and uses the specified value sets.
- The tester uses visual inspection of the CDA® document XML and human readable content to verify that the CDA® document reflects the data entered into the Health IT Module.
| System Under Test | Test Lab Verification |
|---|---|
OR (Approved SVAP Version)
|
|
§ 170.315 (f)(7) Transmission to public health agencies – health care surveys—
Create health care survey information for electronic transmission in accordance with the standard specified in § 170.205(s)(1).
Applies to entire criterion
Standards Version Advancement Process (SVAP) Version(s) Approved
HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm
Optional
For more information, please visit the Standards Version Advancement Process (SVAP) Version(s) page.
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- Accessibility-centered design (§ 170.315(g)(5)): When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
This certification criterion was adopted at § 170.315(f)(7). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
- § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- End-user device encryption (§ 170.315(d)(7))
- Encrypt authentication credentials (§ 170.315(d)(12))
- Multi-factor authentication (MFA) (§ 170.315(d)(13))
- If choosing Approach 2:
- For each applicable privacy and security certification criterion not certified using Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the ONC Cures Act Final Rule at 85 FR 25710 for additional clarification.
| Version # | Description of Change | Version Date |
|---|---|---|
| 1.0 |
Initial publication |
03-11-2024
|
- Regulation Text
-
Regulation Text
§ 170.315 (f)(7) Transmission to public health agencies – health care surveys—
Create health care survey information for electronic transmission in accordance with the standard specified in § 170.205(s)(1).
- Standard(s) Referenced
-
Applies to entire criterion
Standards Version Advancement Process (SVAP) Version(s) Approved
HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm
Optional
For more information, please visit the Standards Version Advancement Process (SVAP) Version(s) page.
- Certification Dependencies
-
Conditions and Maintenance of Certification
Real World Testing: Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.
- Quality management system (§ 170.315(g)(4)): When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
- Accessibility-centered design (§ 170.315(g)(5)): When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
- Privacy & Security Requirements
-
This certification criterion was adopted at § 170.315(f)(7). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(f) criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
- The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (f) criterion unless it is the only criterion for which certification is requested.
- As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
- § 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please review the Privacy and Security CCG.
- If choosing Approach 1:
- Authentication, access control, and authorization (§ 170.315(d)(1))
- Auditable events and tamper-resistance (§ 170.315(d)(2))
- Audit reports (§ 170.315(d)(3))
- End-user device encryption (§ 170.315(d)(7))
- Encrypt authentication credentials (§ 170.315(d)(12))
- Multi-factor authentication (MFA) (§ 170.315(d)(13))
- If choosing Approach 2:
- For each applicable privacy and security certification criterion not certified using Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the ONC Cures Act Final Rule at 85 FR 25710 for additional clarification.
- Revision History
-
Version # Description of Change Version Date 1.0 Initial publication
03-11-2024 - Testing
-
Testing Tool
NIST General Validation Tool (GVT) - select NHCS CDA Release 3 validator in "Tool Scopes" section
Test Tool Documentation
National Health Care Surveys IG Release 1.2 Validator User Guide
National Health Care Surveys IG Release 1 Validator User Guide
Criterion Subparagraph Test Data (f)(7) SVAP Refer to NIST General Validation Tool (GVT) - select NHCS CDA Release 3 validator in "Tool Scopes" section
Certification Companion Guide: Transmission to public health agencies — health care surveys
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the Certification Regulations page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
The below table outlines whether this criterion has additional Maintenance of Certification dependencies, update requirements and/or eligibility for standards updates via SVAP. Review the Certification Dependencies and Required Update Deadline drop-downs above if this table indicates “yes” for any field.
| Base EHR Definition | Real World Testing | Insights Condition | SVAP | Requires Updates |
|---|---|---|---|---|
| Not Included | Yes | No | Yes | No |
Applies to entire criterion
Technical outcome – Health IT can create health care survey data for electronic transmission in compliance with all mandatory elements and requirements of the HL7® Implementation Guide (IG) for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – US Realm, Draft Standard for Trial Use, December 2014.
Clarifications:
- For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
- In response to a comment requesting clarification regarding the surveys that were included in the IG, ONC incorrectly indicated in the 2015 Edition Final Rule that the NHCS was included in the adopted version of the IG (version 1.0) [80 FR 62669]. This was due to a conflation of the name of the IG (NHCS IG), confusion with the three setting types of the two surveys (NAMCS and NHAMCS) included in version 1.0 of the IG, and the pending inclusion of the NHCS in Release 1.1 of the IG. ONC clarifies that the NHCS is not included in the adopted version 1.0 of the IG and is not currently available for certification as part of the 2015 Edition.
- ONC clarified in the 2015 Edition Final Rule that the entire IG would be covered as part of certification. [80 FR 62669] ONC further clarifies that certification to each survey within the IG would be based on the selection of the health IT developer. ONC expects that such selection would be based on the healthcare setting that the Health IT Module presented for certification is intended to support. To illustrate, a Health IT Module designed to support providers practicing in:
- An office setting would be presented for certification to NAMCS.
- A hospital-based outpatient setting would be presented for certification to NHAMCS with the appropriate IG-identified outpatient constraints.
- An emergency department would be presented for certification to NHAMCS with the appropriate IG-identified emergency department constraints.
- Since the publication of the 2015 Edition Final Rule, HL7® has published newer versions of the NHCS IG. These versions are Release 1.1 (November 2015) and Release 1.2 (August 2016). Release 1.2 enables collection of inpatient data which is critical to the National Center for Health Statistics' (NCHS) mission and is responsive to stakeholders’ comments on Release 1.1. Because of these improvements, NCHS updated its reporting requirements and system capacity to support Release 1.2 effective January 1, 2018. Accordingly, ONC permits and provides testing and certification support for conformance to NHCS IG Release 1.2 to meet this criterion. Health IT already certified to NHCS IG Release 1.0 will not be required to retest or recertify to Release 1.2.
- The health care surveys for electronic transmission will be collected by CDC only rather than at the jurisdictional level. [see also 80 FR 62669]
- Health IT developers can choose to use the flexibility of the Standards Version Advancement Process (SVAP) to use more advanced version(s) of standard(s) than the version(s) incorporated by reference in the regulation for this certification criterion. To comply with the Maintenance of Certification requirement in § 170.405(b), a developer that chooses to pursue such updates must include in their Real World Testing plan each Certified Health IT Module updated to newer version(s) of any standard(s) prior to August 31 of the year in which their updates were made and test each Module the following calendar year for conformance to all applicable criteria within its scope, including the newer version(s) of any standard(s).
- Developers updating their already Certified Health IT Modules who choose to leverage the SVAP flexibility will be required to provide advance notice to all affected customers and its ONC-ACB. To be open and transparent to the public, health IT developers must also provide its ONC-ACB with a publicly accessible hyperlink to the SVAP Notice to be published with the Module on the ONC Certified Health IT Product List (CHPL).
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Technical outcome – Health IT can create health care survey data for electronic transmission in compliance with all mandatory elements and requirements of the HL7® Implementation Guide (IG) for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – US Realm, Draft Standard for Trial Use, December 2014. Clarifications:
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